Page:United States Statutes at Large Volume 106 Part 1.djvu/181

 PUBLIC LAW 102-282—MAY 13, 1992 106 STAT. 149 Public Law 102-282 102d Congress An Act To authorize the Secretary of Health and Human Services to impose debarments w ^^o 10^2 and to take other action to ensure the integrity of abbreviated drug applications — nAKA^— under the Federal Food, Drug, and Cosmetic Act, and for other purposes. IH.R. ^ 4o4J Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, E^f<frc*^iMrSf SECTION 1. SHORT TITLE; REFERENCE; FINDINGS; TABLE OF CON- Act of 1992. TENTS. (a) SHORT TITLE.— This Act may be cited as the "Generic Drug 21 USC 301 Enforcement Act of 1992". note. (b) REFERENCE.—Whenever in this Act cm amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act. (c) FINDINGS. —The Congress finds that— 21 USC 335a (1) there is substantial evidence that significant corruption note, occurred in the Food and Drug Administration's process of approving drugs under abbreviated drug applications, (2) there is a need to establish procedures designed to restore and to ensure the integrity of the abbreviated drug application approval process and to protect the public health, and (3) there is a need to establish procedures to bar individuals who have been convicted of crimes pertaining to the regulation of drug products from working for companies that manufacture or distribute such products. (d) TABLE OF CONTENTS.— Sec. 1. Short title; reference; findings; table of contents. Sec. 2. Debarment and other restrictions. "Sec. 306. Debarment, temporary denial of approval, and suspension. "(a) Mandatory debarment. "(b) Permissive debarment. "(c) Debarment period and considerations. "(d) Termination of debarment. "(e) Publication and list of debarred persons. "(f) Temporary denial of approval. "(g) Suspension authority. "(h) Termination of suspension. "(i) Procedure. "(j) Judicial review. "(k) Certification. "(1) Applicability.". Sec. 3. Civil penalties. "Sec. 307. Civil penalties. "(a) In general. "(b) Procedure. "(c) Judicial review. "(d) Recovery of penalties. "(e) Informants.. Sec. 4. Authority to withdraw approval of abbreviated drug applications. "Sec. 308. Authority to withdraw approval of abbreviated drug applications. "(a) In general. "(b) Procedure.

�